Kornimate/medical-research-clean huggingface dataset:
study of an investigational nasal aerosol or placebo nasal aerosol in children (ages 6-11) with seasonal allergies

Conditions: Seasonal Allergic Rhinitis; SAR

Summary: the purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).


Eligibility criteria:
inclusion criteria: * male or female subjects 6 to 11 years of age, as of the screening visit (sv) * a documented history of sar to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study screening visit (sv). * a demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce sar through a standard skin prick test. * other criteria apply exclusion criteria: * history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit \[sv\]) * history of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the screening visit (sv), or development of a respiratory infection during the run-in period. * active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). history of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the screening visit (sv) is acceptable * have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial * other criteria apply

Keywords: allergies hayfever
life nis, gerd-patients - evaluation of burden of disease determined by gerd impact scale (gis)

Conditions: GERD

Summary: evaluate burden of disease in patients with newly occurred upper gi symptoms related to gerd (symptom frequency \& severity, qol, lifestyle modifications, self-medication) - baseline data according to gerd impact scale presenting to specialists, especially internists - evaluate effect of treatment with a acid suppressive therapy on these parameters: looking for improvement of symptom burden and quality of life according to the gerd impact sca


Eligibility criteria:
inclusion criteria: * patients with newly occured upper gi symptoms related to gerd

Keywords: gerd nis
spm 927 (400mg/day and 600mg/day) as adjunctive therapy in subjects with partial seizures with or without secondary generalization

Conditions: Epilepsy

Summary: male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the united states. the purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide \[spm 927\]) taken orally twice a day for about five months. each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide up to the target dose of 400mg/day or 600mg/day. the target dose or placebo will be maintained for 12 weeks. the study clinic visits will include a medical history and physical exam, electrocardiogram (ecg), blood and urine sample collection, and completion of a seizure diary. patients who complete the study may enroll in an extension trial and receive active study drug.


Eligibility criteria:
inclusion criteria: * epilepsy with partial seizures exclusion criteria: * subject received spm 927 in a previous trial

Keywords: epilepsy with partial seizures
hysterosalpingography and hysteroscopy in icsi

Conditions: Infertility

Summary: unexplained infertility is a rising problem in clinical practice

assessment of uterine cavity is very important before icsi

Eligibility criteria:
inclusion criteria: * women with infertility exclusion criteria: * women with medical disorders
expanded access protocol for boys with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the intent of this protocol is to provide continued access to vamorolone for subjects in the united states who have completed the vbp15-lte, vbp15- 004, or vbp15-006 protocols (and are thereby ineligible to enroll in another trial of vamorolone therapy), during the time a new drug application for vamorolone is under preparation and review.

vamorolone will be shipped to the subject's family by the study site. the patient will receive standard of care treatment and procedures for management of dmd. treating physicians participating in the expanded access program are required to collect and document any physician, patient, or caregiver reported safety events and report to the sponsor. the subject's dose of vamorolone may be increased or decreased within a range of 2.0 to 6.0 mg/kg/day (only doses of 2 mg/kg, 4 mg/kg and 6 mg/kg are allowed), given once daily. administration of vamorolone (taken with an 8 ounce (240 ml) glass of full fat milk, or equivalent high-fat food portion) will be unchanged from the vbp15-lte, vbp15-004, or vbp15-006 studies. in the absence of safety concerns, and while this expanded access protocol isactive, vamorolone may be provided indefinitely or until approval, providedthat the treating physician and family agrees that continued administrationof vamorolone is in the best interest of the child.

Eligibility criteria:
inclusion criteria: * subject's parent or legal guardian has provided written informed consent/hipaa authorization * subject has previously completed at a participating us or canada study site vbp15-lte up to and including the month 24 assessments, or vbp15-004 up to and including the week 48 assessments, vbp15-006 up to and including the week 12 assessment * subject and parent/guardian are willing and able to comply with recommended study drug administration plan, and standard of care follow-up and monitoring as recommended by their treating physician exclusion criteria: * subject had a serious or severe adverse event in study vbp15-lte or vbp15-004 or vbp15-006 that, in the opinion of the treating physician and sponsor, was probably or definitely related to vamorolone use and precludes safe use of vamorolone for the subject in this expanded access program * subject and/or parent/guardian are unable and/or unwilling to comply with regular medical care and follow-up as recommended by their treating physician throughout participation in the vbp15-eap

Keywords: duchenne muscular dystrophy vamorolone vbp-15 dmd
the effect of probiotics on symptoms and intestinal flora in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: to demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * age ≥18 and ≤70 years at visit 1 * ibs according to the rome iii criteria * a score on abdominal pain nrs ≥3 and ≤6 at least two days a week measured the weeks before visit 2 (baseline) * ibs-sss ≥75 and ≤300 at visit 2 (baseline) * ability and willingness to understand and comply with the study procedures exclusion criteria: * known intolerance or allergy to milk products (protein or lactose) or gluten * history of alcohol or substance abuse six months prior to screening * known hepatitis b or c or human immunodeficiency virus (hiv) 1 or 2 * female patients: currently pregnant or breast-feeding or intending to become pregnant during the study * abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator * other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator * other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator * symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator * severe psychiatric disease as judged by the investigator * lack of suitability for participation in the study for any reason as judged by the investigator * use of other probiotic products from visit 1 and throughout the study. * consumption of antibiotic drugs 1 month prior to screening and throughout the study. * consumption of drugs on a regular basis which could interfere with symptom evaluation as judged by the investigator.
use of parniv for early diagnosis of lvf in aecopd

Conditions: Acute Heart Failure; COPD Exacerbation

Summary: left ventricular failure (lvf) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (aecopd). this association is frequently underestimated with regard to the difficulty of clinical diagnosis . the investigators expect that the application of pressure support under niv could be useful in this issue.

acute heart failure (ahf) is a common cause of copd exacerbation however its role is very often underestimated. until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the swan-ganz catheter has been stated as reference. other noninvasive diagnostic methods have been studied, such as systolic time intervals and valsalva maneuver, but their application still difficult in patients with copd exacerbation, especially in emergency department (ed) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the par using non invasive ventilation (niv) for the early identification of left ventricular failure (lvf) in patients presenting to the ed with acute copd exacerbation

Eligibility criteria:
inclusion criteria: * patients with a history of copd * consulted the emergency department for aecopd defined by a respiratory rate \>25c/min, sao2 \ 6kpa were included. exclusion criteria: * hemodynamic instability requiring the use of vasoactive drugs * patients with contraindications to niv (glasgow score \<12, swallowing disorder or severe bronchial obstruction, vomiting, and those with upper airway obstruction or ongoing upper gastrointestinal bleeding and altered bronchial clearance) * non cooperative patients * who refused to give consent.

Keywords: copd left ventricular failure pressure support under niv
shr-a2102 combined with adebrelimab as neoadjuvant therapy for early triple-negative breast cancer

Conditions: TNBC - Triple-Negative Breast Cancer

Summary: this is a prospective, open-label, multicenter phase ii study evaluating the efficacy and safety of of shr-a2102 in combination with adebrelimab in early triple-negative breast cancer(tnbc)

this study plans to enroll patients with early-stage tnbc. the patients will first receive 8 cycles of neoadjuvant therapy, with imaging examinations conducted every 2 cycles to evaluate the treatment response. subjects who complete the 8 cycles and are suitable for surgery will undergo surgical treatment after the completion of neoadjuvant therapy. the postoperative adjuvant therapy will last for one year. subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.

Eligibility criteria:
inclusion criteria: 1. female patients aged ≥ 18 years; 2. histopathologically confirmed triple-negative invasive breast cancer, with no previous systemic anti-cancer treatment specifically for breast cancer; 3. at least one measurable target lesion according to recist v1.1; 4. ecog performance status score of 0 to 1; 5. life expectancy ≥12 weeks; 6. adequate bone marrow reserve and organ system function reserve; 7. participants should be able and willing to comply with the study protocol requirement; exclusion criteria: 1. breast cancer not histologically confirmed; 2. previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 3. previous treatment with anti-programmed cell death protein 1 (anti-pd-1), anti-programmed death ligand 1 (anti-pd-l1), or anti-pd-l2 drugs, or other immunotherapy; 4. concurrent receipt of any other form of anti-cancer therapy; 5. history of a second primary malignancy, except for adequately treated skin cancer; 6. participation in other drug clinical trials within 4 weeks before enrollment; 7. major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures; 8. presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence; 9. uncontrolled or significant cardiovascular and cerebrovascular diseases; 10. subjects with known or suspected interstitial pneumonia; 11. presence of active hepatitis b, hepatitis c, liver cirrhosis; or severe infections requiring antibiotic, antiviral, or antifungal drug control; 12. known inherited or acquired bleeding and thrombotic tendencies; 13. known allergy or contraindication to the study drug and its excipients; 14. pregnant or lactating female patients; 15. history of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.
treatment of bardet-biedl-syndrome with metformin for evaluation of a possible visual improvement

Conditions: Bardet-Biedl Syndrome; Visual Impairment

Summary: in this prospective pilot study without control group children and young adults (10-25 years old) diagnosed with bardet-biedl syndrome and treated with metformin for their adipositas will be evaluated for a possible additional effect of metformin on visual acuity.

within experiments with animals a positive effect of metformin concerning the photo receptors was shown. several patients of the university hospital tübingen with bardet-biedl-syndrome and metformin therapy due to their adipositas reported a subjective improvement of the visual acuity which was confirmed by opthalmologic tests. this will be checked in a prospective pilot study without control group including children and young adults (10-25 years old) diagnosed with bardet-biedl syndrome and treated with metformin for their adipositas. therefore a possible additional effect of metformin on visual acuity will be evaluated under controlled conditions.

Eligibility criteria:
inclusion criteria: * clinically confirmed bardet-biedl-syndrome * visual acuity between 0.05 and 0.8 * age \>=10 year to \<25 years * visual field iii4e or v4e with diameter \>=5°, if ii4e not seen * informed consent of patient and/or legal representative exclusion criteria: * hypoglycaemia (\<50mg/dl) * therapy with metformin within the last three months * participation in another clinical trial * pregnancy, lactation * any contra indication concerning metformin therapy * renal failure (creatinine clearance \< 60ml/min) * any acute disorder accompanied by clouding of consciousness * acute or chronic disorders possible accompanied by tissue hypoxia * liver insufficiency, alcohol abuse * not fluent in german language
the amor method: resilience training for parents of children with autism

Conditions: Autism Spectrum Disorder

Summary: we will evaluate whether a resilience training program which includes group and individual parent training will be effective in improving optimism and resiliency in parents of young children with autism spectrum disorders (asd). by observing the level of parent optimism and resiliency before and after intervention, we will be able to determine whether the intervention is effective in improving parent resilience.


Eligibility criteria:
inclusion criteria: parents eligible to participate include parents: a) english-speaking, b) of a child aged 4:0 to 10:11 years, c) with a previous diagnosis of asd and evidence of current social impairment (srs-2) and repetitive behaviors (rbs-r), and d) who are able to consistently participate in sessions. given budgetary constraints, direct diagnostic testing will not be feasible. instead, child diagnostic status will be confirmed through review of the child's medical record for evidence that the child previously met ados criteria for asd and shows clinically significant social impairment at baseline (srs-2 t\>65). parents who are not eligible to participate include parents: a) with severe psychiatric, genetic, or medical disorder among parents and/or children, b) taking psychiatric medication, and c) with elevated resilience scores at baseline (total score \>80 on cd-risc). the dsm-5 ccsm will be administered to parents to screen for parent mental illness. any identified issues on the dsm-5 ccsm will be investigated further by the pi to rule out severe psychiatric disorders. exclusion criteria: a) severe psychiatric, genetic, or medical disorder among parents and/or children, b) parents taking psychiatric medication, and c) parents with elevated resilience scores at baseline (total score\>80 on cd-risc). the dsm-5 cross cutting symptom measure (dsm-5 ccsm) will be administered to parents to screen for parent mental illness. any identified issues on the dsm-5 ccsm will be investigated further by the pi to rule out severe psychiatric disorders. these families will be referred for behavioral consultation (available in our clinic) and then be reconsidered for group participation.
evaluation of a new local drug delivery in the nonsurgical treatment of periodontitis

Conditions: Periodontitis

Summary: the aim of the planned randomized clinical trial will be the clinical and microbiological evaluation of the new intracellular drug developed in cooperation with the chair and department of drug form technology of the medical university and the department and department of pharmaceutical microbiology and parasitology of the medical university in wrocław.

clinical trials will be conducted on 60 patients of the department of periodontology of the medical university of wrocław with 3rd or 4th degree generalized periodontitis, who will consent to participate in the research by signing the documentation approved by the bioethics committee of our university. the exclusion criteria will be: the presence of general diseases affecting the clinical condition of the periodontium, hypersensitivity to the drug used in the carrier system, lack of proper oral hygiene, active nicotinism and age over 65 years. the research will be carried out according to the scheme of parallel randomization and double-blinded trial in two groups of 30 people. all qualified patients will undergo an initial period of periodontal treatment and scaling / root planning. in the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side, placebo with a change of side in every second patient. in the other group, the drug under evaluation or placebo will be used on one side, and the srp treatment with alternation of sides on the other side for every second patient.

Eligibility criteria:
inclusion criteria: * stage- 3rd degree generalized periodontitis * stage 4th degree generalized periodontitis exclusion criteria: * presence of general diseases affecting the clinical condition of the periodontium, * hypersensitivity to the drug used in the carrier system, * lack of proper oral hygiene * active nicotinism * age over 65 years
study of first line treatment of chronic graft versus host disease with the association of ciclosporine, corticosteroids and rituximab (protocol r-gvhd)

Conditions: Graft Versus Host Disease

Summary: the main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic chronic graft versus host disease (gvhd) and treatment with the combination of ciclosporine, prednisone and rituximab as first line treatment.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) who have received a first allogeneic stem cell transplantation for a hematological disease * confirmed diagnosis of first episode of chronic gvhd requiring systemic immunosuppressive therapy. chronic gvhd diagnosis is defined according to the nih working group consensus. chronic gvhd diagnosis will be based on the evaluation of the severity of the different clinical manifestations including : 1. ocular, oral and mucosal symptoms, 2. performance status evaluation, 3. pulmonary function evaluation, 4. cutaneous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible, 5. evaluation of the musculoskeletal manifestations, especially the amplitude of the rele-vant articulations, 6. evaluation of liver involvement (total bilirubin, transaminases, phosphatase alcalines and gamma gt). * any source of hematopoietic stem cells is authorized. * any category of conditioning regimen prior to allo-sct is authorized. * any type of stem cell donors is authorized. * signed informed consent. * any prior gvhd prophylaxis previously used is accepted. * absence of contra-indications to the use of rituximab. * subjects affiliated with an appropriate social security system. * women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 3 months following the end of the study. exclusion criteria: * patient developing acute gvhd (whether early or "late onset" form) * a "limited" form of chronic gvhd not requiring systemic immunosuppressive therapy * treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. * gvhd occurring following donor lymphocytes infusion (dli) * not the first episode of chronic gvhd needing systemic immunosuppressive therapy * neutropenia \<500/µl * second allogeneic stem cell transplant * uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient's death within 1 month after the start of therapy * severe neurological or psychiatric disorders * denied informed consent * pregnancy

Keywords: adult patients (≥18 years) first allogeneic stem cell transplantation first episode of chronic gvhd requiring systemic immunosuppressive therapy
implementation of the hospital to home (h2h) heart failure initiative

Conditions: Heart Failure

Summary: this study determines if a community of practice of clinicians and quality improvement specialists can be used to implement a national quality initiative known as hospital to home (h2h). this quality initative is designed to reduced readmission rates for patients with heart failure or heart attack by improving the transition of care upon discharge.


Eligibility criteria:
inclusion criteria: * va medical centers are the unit of randomization. a medical center will be included if had at least 20 patients discharged with a principal diagnosis of heart failure in 2008